Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk children (the PREGRALL study) protocol for a randomised controlled trial

Clémentine Cabridain (1) , Hélène Aubert (2) , Bertrand Kaeffer (2) , Virginie Badon (2) , Marion Boivin (2) , Vincent Dochez (2) , Norbert Winer (2) , Elodie Faurel-Paul (2) , Lucie Planche , David Riochet (2) , Annabel Maruani (3, 4) , Franck Perrotin (3) , Catherine Droitcourt (5, 6) , Linda Lassel (5) , Martine Tching-Sin (2) , Natasha K Rogers (7) , Marie Bodinier (8) , Sébastien Barbarot (2)

1 PhAN - Physiopathologie des Adaptations Nutritionnelles
2 CHU Nantes - Centre Hospitalier Universitaire de Nantes
3 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
4 CIC - Centre d’Investigation Clinique [Tours] CIC 1415
5 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
6 REPERES - Recherche en Pharmaco-épidémiologie et Recours aux Soins
7 UON - University of Nottingham, UK
8 BIA - Unité de recherche sur les Biopolymères, Interactions Assemblages

Introduction - Atopic dermatitis (AD) is a chronic inflammatory disease affecting 10%-15% of children in Europe. There is a need for new primary preventive therapeutic strategies in at-risk populations. Recent research has indicated that atopic diseases are associated with a disrupted gut microbial 'balance' in early life raising the possibility that interventions which yield optimal patterns of microflora could improve host's health. Prebiotics, sugars with immunomodulatory properties that stimulate the diversity of the digestive microbiota, are ideal candidates for such research. So far, most clinical trials have focused on improving infant gut colonisation postnatally. However, prenatal life is a crucial period during which different tolerance mechanisms are put in place. We aim to determine whether antenatal prebiotics supplementation prevents AD in high-risk children. Methods and analysis - This is a randomised, multicentre, double-blind, trial to evaluate the effectiveness of antenatal prebiotic maternal supplementation (galacto-oligosaccharide/inulin) in pregnant women versus placebo on the occurrence of AD at 1 year of age in at-risk children (defined as having a maternal history of atopic disease). Participating women will be randomised to daily ingestion of a prebiotics or placebo (maltodextrin) from 20 weeks' gestation until delivery. The primary outcome is the prevalence of AD at 1 year of age, using the version of the UK Working Party Diagnostic Criteria optimised for preventive studies. Key secondary endpoints are AD severity, quality of life and prebiotics tolerance. The target sample size is 376 women (188 patients per group) which will provide 80% power to detect a 33% reduction of the risk of AD in the verum group (α=0.05). The primary analysis will be based on the intention-to-treat principle. Ethics and dissemination - Results will be presented in peer-reviewed journals and at international conferences. Ethics approval for the study was obtained from the institutional ethical review board of 'Comité de Protection des Personnes Sud Ouest-Outre-Mer III' of the University Hospital Centre of Bordeaux (2017/13). Trial registration number - NCT03183440; Pre-results.

Mots clés: eczema; paediatric dermatology; dermatology

Domaines: Sciences du Vivant [q-bio]

Clémentine Cabridain, Hélène Aubert, Bertrand Kaeffer, Virginie Badon, Marion Boivin, et al.. Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk children (the PREGRALL study) protocol for a randomised controlled trial. BMJ Open, 2019, 9 (4), pp.e024974. ⟨10.1136/bmjopen-2018-024974⟩. ⟨hal-02121119⟩